Boostrixa booster vaccine combining
Tetanus Toxoid, Reduced
Diphtheria Toxoid, and Acellular
Pertussis, Adsorbedhas received
FDA approval for use in children and
adolescents 10 to 18 years old. Boostrix,
produced by GlaxoSmithKline, is
the first pertussis vaccine in the United
States for children >7 years old.1

Most people are vaccinated during
childhood from diphtheria, tetanus,
and pertussis with a combination vaccine
(DTaP). The DTaP vaccination
series is completed around age 5.2,3
Although regular boosters of tetanus
and diphtheria are required and available
as a combination vaccine (Td),
additional vaccination for pertussis
has not been available. Immunity
begins to fade 5 to 10 years after
immunization, leaving the adolescent
population especially susceptible to
pertussis infections.1

Adolescents with pertussis, often
undiagnosed due to its less-symptomatic
presentation, often act as a host to the
disease. Bordetella pertussis, the organism
responsible for the disease, is highly contagious
and easily transmitted through
airborne droplets in sneezes or coughs.
In infants, who have not yet developed
the immune system to ward off such
infections, pertussis can be deadly.1

Pertussis, also known as "whooping
cough,"typically presents similarly to
the common cold; patients may complain
of mild fever, runny nose, and
coughing. As the disease progresses,
the cough usually becomes severe and
exhibits as a classic high-pitched
"whooping"sound. Adolescent patients,
however, generally do not
develop the "whooping"noise associated
with pertussis.1

Diphtheria usually presents as
malaise, sore throat, and low-grade
fever. Later in the disease, a membrane
may form over the airway, creating respiratory
obstruction. Five percent to
10% of individuals infected with diphtheria
die from the disease; this rate
rises to up to 20% in patients <5 and
>40 years old.

Tetanus is caused by bacteria typically
found in soil and manure. Initial
symptoms include lockjaw, neck and
abdomen stiffness, and difficulty swallowing.
Later symptoms include fever,
elevated blood pressure, and severe
muscle spasms.

Clinical Trials

A US phase 3 clinical trial of Boostrix
involving ~3000 patients aged 10 to 18
years demonstrated Boostrix to be of
comparable safety and efficacy to an
already-approved Td [Tetanus and
Diphtheria Toxoids for Adult Use] vaccine.
Antipertussis antibodies in the
Boostrix patients were found to be
noninferior to levels in infants vaccinated
with the standard DTaP vaccine.1

An observer-blinded, randomized,
controlled, multicenter clinical trial of
4114 patients aged 10 to 18 years compared
vaccination with either 1 dose of
Boostrix or an adult Td vaccine. Serology
reports established that both
groups obtained antidiphtheria and
antitetanus levels that indicated
immunity. The Boostrix group, however,
demonstrated antipertussis levels
similar to those in vaccinated infants
with established pertussis immunity.1

Warnings, Precautions, andAdverse Events

Use as a primary vaccination has
not yet been established. Boostrix
should not be given to anyone with a
history of hypersensitivity to any vaccine
containing tetanus toxoid, diphtheria
toxoid, or pertussis. Encephalopathy,
progressive neurologic
disorder, and uncontrolled epilepsy
are contraindications for the administration
of Boostrix. Additional caution
should be used in patients experiencing
fever >105ºF, collapse, shock, or
inconsolable crying within 48 hours of
administration or seizures within 3
days of administration.4

Pain, redness, and swelling at the
site of injection were the most common
local reactions to Boostrix. Systemic
adverse effects included headache
and fatigue.4

Dosage and Administration

Boostrix should be administered to
the deltoid muscle as a 0.5-mL intramuscular
injection. It never should be
administered intravenously or subcutaneously.

Dr. Holmberg is a pharmacist with PhoenixChildren's Hospital, Phoenix, Ariz.